Lumbar Plexus Nerve Block, Osteoarthritis of Hip, Other Acute Postoperative Pain, Parasacaral (Sciatic) Nerve Block, Peripheral Nerve Block, Regional Anesthesia, Total Hip Arthroplasty
Conditions
Keywords
Peripheral Nerve Block, Total Hip Replacement
Brief summary
The purpose of this research study is to evaluate the analgesic efficacy of adding a single shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients undergoing total hip replacement.
Detailed description
This prospective study is intended to assess the efficacy of placing a parasacral (sciatic) nerve block in addition to a lumbar plexus block for postoperative analgesia following total hip arthroplasty. Although the placement of a lumbar plexus block alone has become accepted as the standard of care at UPMC for postoperative analgesia following total hip arthroplasty, the addition of a parasacral (sciatic) nerve block may provide the advantage of blocking the superior gluteal nerve and nerve to the quadratus femoris which both supply small articular sensory branches to the posterior hip capsule.
Interventions
PROCEDUREContinuous Lumbar Plexus Block
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
PROCEDUREParasacral Nerve Block
A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.
DRUGRopivacine 0.2%
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm.
DRUGBupivacaine 0.0625%
In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
Sponsors
Rita Merman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has signed and dated an Informed Consent Form. 2. Subject is classified as a ASA (American Society of Anesthesiologists) status I-III 3. Subject is age 18- 75 years old. 4. Subject is having primary total hip arthroplasty 5. No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state) 6. Patient willing to receive spinal anesthesia as operative anesthesia 7. No known drug allergies to study medications 8. Patients not expected to receive therapeutic anticoagulation in the postoperative period.
Exclusion criteria
1. Subject inability to provide adequate informed consent. 2. Age younger than 18 years or older than 75 years 3. Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state. 4. ASA (American Society of Anesthesiologists) physical status of IV or greater 5. Any chronic painful conditions 6. Preoperative opioid use 7. Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Assessment | 6 hours after the start of surgery | Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively | 48 hours after the start of the surgery | — |
| Amount of Oxycodone for the First 48 h Post Operatively | 48 hours after the start of the surgery | Including number of dose and mg). |
| Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively | 48 hours after the start of the surgery | — |
| Total Amount of Local Anesthetic in 48 Hours Post Operatively | 48 hours after the start of the surgery | Combined amount of Bupivacaine Boluses + Continuous infusion in (cc) |
| Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively | 48 hours after the start of the surgery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complications (e.g. Frequency of Foot-drop). | 48 hours after the start of the surgery | Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, Foot Drop, allergic reaction will be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Lumbar Plexus Block With Parasacral Nerve Block Experimental: Continuous Lumbar Plexus Block with Parasacral Nerve Block
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected. | 5 |
| Lumbar Plexus Nerve Block Arm: Active Comparator: Lumbar Plexus Nerve Block
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
No sham/placebo parasacral (sciatic) blocks will be performed in this group. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Total | Lumbar Plexus Nerve Block |
|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 2.86 | 57.7 years STANDARD_DEVIATION 5.54 | 58.6 years STANDARD_DEVIATION 7.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Numeric Rating Scale (NRS) Pain Assessment
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time frame: 6 hours after the start of surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain at Rest | 2.6 units on a scale | Standard Deviation 2.19 |
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain with Movement | 3.5 units on a scale | Standard Deviation 1.67 |
| Lumbar Plexus Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain at Rest | 3.6 units on a scale | Standard Deviation 1.67 |
| Lumbar Plexus Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain with Movement | 5 units on a scale | Standard Deviation 1.87 |
Primary
Numeric Rating Scale (NRS) Pain Assessment
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time frame: 24 hours after the start of surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain at Rest | 4.25 units on a scale | Standard Deviation 2.75 |
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain with Movement | 7.25 units on a scale | Standard Deviation 2.5 |
| Lumbar Plexus Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain at Rest | 2.2 units on a scale | Standard Deviation 1.92 |
| Lumbar Plexus Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain with Movement | 4.4 units on a scale | Standard Deviation 0.89 |
Primary
Numeric Rating Scale (NRS) Pain Assessment
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time frame: 48 hours after the start of surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain at Rest | 1 units on a scale | Standard Deviation 0 |
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain with Movement | 8 units on a scale | Standard Deviation 0 |
| Lumbar Plexus Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain at Rest | 2 units on a scale | Standard Deviation 1.14 |
| Lumbar Plexus Nerve Block | Numeric Rating Scale (NRS) Pain Assessment | Pain with Movement | 5 units on a scale | Standard Deviation 1.41 |
Secondary
Amount of Oxycodone for the First 48 h Post Operatively
Including number of dose and mg).
Time frame: 48 hours after the start of the surgery
Population: Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Secondary
Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively
Time frame: 48 hours after the start of the surgery
Population: Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Secondary
Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively
Time frame: 48 hours after the start of the surgery
Population: Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Secondary
Total Amount of Local Anesthetic in 48 Hours Post Operatively
Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)
Time frame: 48 hours after the start of the surgery
Population: Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Secondary
Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively
Time frame: 48 hours after the start of the surgery
Population: Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.
Other Pre-specified
Incidence of Complications (e.g. Frequency of Foot-drop).
Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, Foot Drop, allergic reaction will be recorded
Time frame: 48 hours after the start of the surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | Incidence of Complications (e.g. Frequency of Foot-drop). | 0 Number of complications |
| Lumbar Plexus Nerve Block | Incidence of Complications (e.g. Frequency of Foot-drop). | 0 Number of complications |